Kornimate/medical-research-clean huggingface dataset:
cardiac amyloidosis in spinal stenosis: the cass-study

Conditions: Cardiac Amyloidosis

Summary: background: a significant portion of cardiac amyloidosis patients have a 5 to 10 years prior history of spinal canal stenosis, reflecting a diagnostic red flag that should raise suspicion for amyloidosis presence. mild troponin release and nt-probnp elevation, both serum cardiac biomarkers, often coincide with cardiac amyloidosis. early cardiac amyloidosis treatment improves survival, warranting timely diagnosis. study aim: to test a prospective screening strategy, based on serum cardiac biomarkers, to increase early detection of cardiac amyloidosis in patients with spinal canal stenosis. design: single-centre prospective observational non-interventional diagnostic study. methods: consecutive patients during a one-year period in az sint-jan bruges, without known cardiac amyloidosis history and scheduled for spinal canal stenosis surgery, will have cardiac evaluation including serum cardiac biomarker (high-sensitive troponin t and nt-probnp) assessment, electrocardiography and transthoracic echocardiography. during surgery, all patients will undergo ligamentum flavum biopsy to evaluate presence and burden of transthyretin amyloid deposition (congo-red staining and immune histochemistry). all patients with suspicion for cardiac amyloidosis will undergo further diagnostic testing (including laboratory test and bone scintigraphy). a chronologic cascade screening process will be used starting with abnormal serum cardiac biomarkers (high-sensitive troponin t ≥ 14 ng/ml and/or nt-probnp \> 125 pg/ml), followed by electrocardiography, transthoracic echocardiography and finally ligamentum flavum biopsy results. the diagnostic performance of this biomarker-based strategy will be compared to electrocardiography, echocardiography and ligamentum flavum biopsy. conclusion: it is hypothesised that serum cardiac biomarker testing in patients undergoing spinal canal stenosis surgery represents a simple and valuable prospective screening strategy for early detection of cardiac amyloid(osis).


Eligibility criteria:
inclusion criteria: * cervical or lumbar spinal canal stenosis, scheduled for spinal surgery * \> 18 years old exclusion criteria: prior diagnosis of cardiac amyloidosis and evident alternative explanations for troponin and/or nt-probnp elevation are the main reasons for exclusion. * known cardiac amyloidosis * severe valvular regurgitation or stenosis * left ventricular ejection fraction (lvef) \< 40% * glomerular filtration rate (gfr) ≤ 25 ml/kg/min or dialysis * recent heart failure admission ≤ 1 month * recent myocarditis ≤ 3 months * recent acute coronary syndrome ≤ 1 month * recent percutaneous coronary intervention (pci) ≤ 1 month * recent cardiac surgery ≤ 3 months * active or planned pregnancy * unwilling to participate or provide signed informed consent
metabolic effects of paricalcitol

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin d, has beneficial effects on metabolic abnormalities in people with stage 3-4 chronic kidney disease (ckd).

persons with chronic kidney disease (ckd) are at markedly increased risk of death, particularly from cardiovascular disease (cvd). a number of metabolic abnormalities may contribute to adverse health outcomes in ckd, including glucose intolerance, altered immune cell function, and oxidative stress. each of these metabolic stressors is a known complication of ckd. since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in ckd. this study will test whether oral paricalcitol, an active form of vitamin d, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.

Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate of 15-59 ml/min/1.73m2 * fasting glucose 100-125 mg/dl * 18 years and older exclusion criteria: * diagnosed with diabetes mellitus * use of diabetes medications (insulin or oral hypoglycemics) * prior dialysis or transplantation * planning to leave the area within 6 months * participation in another clinical trial within 30 days * treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks * serum calcium more than 10.2 mg/dl * pregnancy or breast-feeding * change in dose (within 8 weeks) of fibrates, niacin, ace inhibitors, angiotensin receptor blockers, thiazide diuretics, beta-blockers, cholecalciferol or ergocalciferol * incontinent of urine * cancer (other than skin cancer) within 5 years * tuberculosis * sarcoidosis

Keywords: chronic kidney disease vitamin d paricalcitol placebo kidney renal oxidative stress immune cell function glucose glucose tolerance
dose escalation and expansion of bbo-10203 in advanced solid tumors (breaker-101)

Conditions: Solid Tumor, Adult; Metastatic Breast Cancer; Advanced Breast Cancer; HER2 Mutation-Related Tumors; HER2-positive Metastatic Breast Cancer; HER2-Positive Advanced Breast Cancer; KRAS Mutant Metastatic Colorectal Cancer; Metastatic Lung Cancer; Metastatic Colorectal Cancer; Advanced Lung Cancer

Summary: first in human study to evaluate the safety, tolerability, and pharmacokinetics (pk) of bbo-10203, a pi3kα:ras breaker, alone and in combination with trastuzumab in patients with advanced solid tumors.

this is an open-label, multi-center phase 1a/1b study designed to evaluate the safety, tolerability, preliminary antitumor activity, and pk of bbo-10203 as a single agent and in combination with trastuzumab in patients with locally advanced unresectable or metastatic (ie, advanced) solid tumors. the study includes a dose escalation phase, and an expansion phase.

Eligibility criteria:
inclusion criteria: * locally advanced and unresectable or metastatic her2-positive advanced breast cancer (abc), hr-positive, / her2-negative advanced breast cancer, kras mutant advanced colorectal cancer (acrc), or kras mutant advanced non-small cell lung cancer (ansclc) * measurable disease by recist v1.1 * eastern cooperative oncology group (ecog) performance status (ps) 0-1 * adequate lvef assessed by echo or muga * patients with her2-positive abc: must have had at least 2 prior lines of anti-her2-directed therapy. only 1 prior line is acceptable where there is no other regionally available standard of care (soc). * patients with hr-positive, her2-negative abc, kras mutant acrc or ansclc: must have progression on, or disease recurrence after, all available soc treatments or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate soc therapy. exclusion criteria: * patients with her2+ abc who have had more than 1 prior line of therapy with an antibody-drug conjugate * patients with kras mutant acrc who have brafv600e mutation, her2amp, or dmmr/msi-h tumors * patients with kras mutant ansclc who have tumors with other targetable driver mutations (eg, egfr, anaplastic lymphoma kinase, ros1/braf/ret/met/egfr exon20 insertion/ntrk/her2) * patients with untreated brain metastases (exceptions apply for her2+ abc per protocol) other inclusion/exclusion criteria are specified in the protocol

Keywords: breaker-101 bridgebio oncology therapeutics bbot phase1 phase 1a/1b trastuzumab breast colorectal non-small cell lung cancer crc nsclc her2+ her2-positive hr+ her2- her2-negative metastatic cancer advanced cancer hr-positive
impact of unrestrictive exercise following mid-urethral sling surgery

Conditions: Stress Urinary Incontinence

Summary: to determine the impact of unrestricted postoperative activity on intermediate- and long-term continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence. to assess the natural return to baseline activity level when patients are unrestricted following mid-urethral sling surgery with or without concomitant anterior or posterior pelvic organ prolapse repair.

over the last decade, the mid-urethral sling has become the new gold standard in the management of stress urinary incontinence because of its high success rate and minimally invasive nature. however, postoperative management has not kept pace with the modernization of sling surgery. although formal guidelines regarding the resumption of normal activity levels have not been established, it is general practice to restrict exercise for a minimum of six weeks after surgery. for the study, if immediate resumption of normal activity has no impact on intermediate- and long-term continence outcomes, it may result in improved quality of life and cost savings from a societal perspective.

Eligibility criteria:
inclusion criteria: * non-pregnant female * self-reported stress urinary incontinence * incontinence demonstrated on physical exam and/or by an urodynamics study * planned mid-urethral sling surgery * available for 2 years of follow-up * willing and able to complete study assessments per the judgment of the treating clinician * willing and able to provide written informed consent exclusion criteria: * age \<18 years at time of enrollment * concomitant prolapse surgery other than anterior colporrhaphy * currently pregnant or \<12 months post-partum * unable to read, write, or comprehend english
bivalirudin in elderly patients with acute st-segment elevation myocardial infarction

Conditions: STEMI; Percutaneous Coronary Intervention; Aged

Summary: the study is an investigator-sponsored, prospective, multicenter, randomized, open-label study designed to compare efficacy and safety between bivalirudin and heparin in elderly patients with acute st-segment elevation myocardial infarction undergoing emergency pci.


Eligibility criteria:
inclusion criteria: * age ≥75 years old; * planned emergency (symptom onset within 24h) pci for acute stemi patients; * life expectancy ≥ 1 year; * provide written informed consent. exclusion criteria: * contraindications to angiography or pci; * active bleeding or bleeding constitution, bleeding tendency, including gi or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc; * other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intra-cerebral mass, aneurysm, etc.); * severe renal insufficiency (egfr \< 30 ml/min/ 1.73 m2); * elevated ast, alt level higher than three times of the normal upper limit; * advanced heart failure (nyha classification grading of cardiac function ≥ ⅲ) * complicated with immune system diseases； * abnormal hematopoietic system：platelet count \ 700 \* 109 / l，white blood cell count \< 3 \* 109/l etc; * suffering from acute infections ,infectious diseases or other serious diseases, such as malignant tumors; * known intolerance, or contraindication to any antithrombotic medication * known allergy to the study drugs and instruments (ufh, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. * non-cardiac co-morbid conditions are present that may result in protocol non-compliance; * patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period; * patient's inability to fully cooperate with the study protocol

Keywords: major adverse cardiac events (maces) bivalirudin
co-axial micro-incision versus co-axial small incision cataract surgery using the stellaris enhancement system

Conditions: Cataract; Aphakia

Summary: the objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the stellaris vision enhancement system.


Eligibility criteria:
inclusion criteria: * subjects must be undergoing bilateral primary in-the-bag intraocular lens (iol) implantation for the correction of aphakia. * subject's ocular media must be clear except for the presence of the cataract in both eyes. exclusion criteria: * subject with any disease, which, in the investigator's opinion, might interfere with the conduct of the study.

Keywords: ocular surgery intraocular lens
oral surgery in patients taking direct oral anticoagulants

Conditions: Anticoagulants and Bleeding Disorders; Surgery; Postoperative Hemorrhage; Dentoalveolar Haemorrhage

Summary: this study evaluates the incidence of postoperative bleeding after oral surgical procedures in patients taking direct oral anticoagulants and in patients taking vitamin k antagonists.

vitamin k antagonists (vka) are widely used in long term prevention and treatment of thromboembolism. in the last few years direct oral anticoagulants (doacs) are available for clinical use, mostly in prevention of stroke and systemic embolisms in patients with nonvalvular atrial fibrillation, and prevention and treatment of venous thrombosis. numerous studies confirmed that minor oral surgical procedures in patients taking vka with therapeutic (international normalized ratio) inr levels can be safely performed without therapy interruption if proper local haemostatic measures are applied. similar recommendations were given for the dental treatment of patients taking doacs, but there is a lack of clinical studies. the aim of this study is to assess the incidence of bleeding complications after oral surgery in patients who continue their doacs or vka medications.

Eligibility criteria:
inclusion criteria: * male and female patients over 18 years * patients taking regularly direct anticoagulant therapy: dabigatran, rivaroxaban or apixaban (doacs group) * patients taking regularly acenocoumarol with inr 2.0-3.5 on the day of the surgery (vka group) * indication for oral surgical procedure * signed informed consent exclusion criteria: * liver or renal disease * coagulopathy * pregnant or breastfeeding women * allergy to lidocaine * patients who stopped taking their anticoagulant medication * patients taking vka with inr \ 3.5 on the day of the procedure

Keywords: oral anticoagulants dabigatran rivaroxaban warfarin oral surgery hemorrhage
repeatability of electroretinogram and visual evoked potential

Conditions: Retinal Disease; Visual Impairment; Vision Disorders

Summary: to assess repeatability of electroretinogram and visual evoked potential in clinical practice

to assess repeatability of electroretinogram in evaluation of retinal function and visual evoked potential in evaluation of visual pathway in clinical practice.

Eligibility criteria:
inclusion criteria: * normal subjects visit banha university hospital seeking regular checkup and subjects asked for erg and vep as a pre-occupational examination. exclusion criteria: * patients previously diagnosed with any retinal disease or visual pathway disease that may affect erg and vep tests.

Keywords: electroretinogram visual evoked potential
nktr-102 versus irinotecan in patients with second-line, irinotecan-naïve, kras mutant, colorectal cancer

Conditions: Colorectal Cancer

Summary: this study will evaluate whether nktr-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. this study will also evaluate how the safety and anti-tumor activity of nktr-102 compares with irinotecan, a cancer drug that is approved for use in the us for treatment of patients with certain types of colorectal cancer.

nktr-102 (topoisomerase i inhibitor polymer conjugate) is a polyethylene glycol (peg) conjugate of irinotecan. irinotecan is a topoisomerase i inhibitor approved worldwide. in the us, irinotecan is indicated as a component of first-line therapy in combination with 5 fluorouracil (5 fu) and leucovorin for patients with metastatic carcinoma of the colon or rectum. irinotecan is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. second-line therapy for colorectal cancer typically involves cetuximab and irinotecan. however, growing evidence indicates that cetuximab (or other egfr inhibitors) is not appropriate therapy for patients with mutant kras. for these patients, irinotecan may be appropriate as a single agent, and a new therapy that could improve upon efficacy and safety would provide an important option for the treatment of advanced colorectal cancer.

Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer * tumor with k-ras mutation exclusion criteria: * more than 1 prior regimen for treatment of metastatic disease

Keywords: colorectal cancer colorectal cancer, second line
comparison of the efficacy/safety of symbicort® turbuhaler®,seretide™ diskus™ 50/500 µg & terbutaline turbuhaler® 0.4 mg

Conditions: Asthma

Summary: the purpose of this study is to compare the efficacy and safety of a variable dose of symbicort with a high fixed maintenance dose of another asthma medication, seretide, in the treatment of asthma.


Eligibility criteria:
inclusion criteria: * diagnosed with asthma since at least 6 months prior to first visit * prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit * at least one asthma exacerbation more than one but less than twelve months prior to first visit exclusion criteria: * respiratory infection affecting asthma within 30 days before first visit * use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit * any significant disease or disorder that may jeopardize the safety of the patient additional inclusion and exclusion criteria will be evaluated by the investigator.

Keywords: asthma
a control study to evaluate the efficacy and safety of ozone-therapy in chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to investigate the efficacy and safety of medical ozone in treatment of chronic hepatitis b patients.

total of 439 patients with chronic hepatitis b were divided according to patients' intention into two arms. 173 patients in arm i were treated with medical ozone therapy with humares which was made in germany for at least 12 weeks.266 patients in arm ii were treated with conventional interferon-α for at least 24 weeks.patients in both groups were followed-up for 24 weeks.virology response, biochemistry response and hepatitis b viral serological response will be studied at 12 weeks after the treatment, at the end of treatment and after 24 weeks of follow-up.

Eligibility criteria:
inclusion criteria: * male or female； * hbsag positive for over 6 months； * alt over 2×uln, tbil less than 80 µmol/l. exclusion criteria: * patient has a history of hemorrhagic or hemolysis disease; * patient has any history of clinical signs/symptoms of hepatic decompensation or serious metabolic hepatic disease; * patient is co-infected with hiv or hcv; * patient is treated with anti-virus drug like interferon or nucleoside analogue in recent 6 months; * patient is treated with immunosuppressive agent for long time, including patient has a history of organ transplantation; * pregnancy; * current alcohol or drug abuse; * difficulty to draw blood through veins; * patient has a history of carcinoma, or finding suggestive of possible hepatocellular carcinoma (hcc), or afp over than 100ng/ml; * patient has a history of any severe physical disease such as cardio-vascular, kidney events, hyperthyroidism or serious electrolyte disturbance; * patient is enrolled in any other clinical trials.

Keywords: chronic hepatitis b medical ozone interferon-α efficacy
tazemetostat for the treatment of moderate to severe covid-19 infection

Conditions: COVID-19 Acute Respiratory Distress Syndrome; Cytokine Release Syndrome

Summary: the purpose of this study is to assess the safety and efficacy of repurposing tazemetostat for the treatment of acute respiratory distress syndrome (ards) or systemic cytokine release syndrome (scrs) in covid-19 patients.

the investigators hypothesize that tazemetostat will mitigate the hyperinflammatory effects of covid-19 infection, prevent respiratory deterioration, and reduce requirements of invasive ventilation. this will be conducted as a phase ii open label study. after being informed about the study and potential risks, all patients giving written informed consent will undergo randomization to receive 800 mg tazemetostat bid for 15 days in addition to standard of care treatment. the duration of the interventional part of the study will last 15 days, additionally the patients will be evaluated at 30 and 90 days for overall clinical status and sequelae. the study will be conducted at a single site (loma linda university medical center).

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study. * male or female, aged 18-85 * diagnosed with q-pcr confirmed infection with sars-cov-2 virus and admitted to the hospital. * receiving non-invasive respiratory support through a nasal cannula or a face mask. * ability to take oral medication and be willing to adhere to the tazemetostat regimen. exclusion criteria: * unable to take po medication. * need for intubation or ecmo. * pregnancy or lactation * known allergic reactions to tazemetostat. * active malignancy (not in remission). * treatment with another investigational drug.

Keywords: systemic cytokine release syndrome due to sars-cov-2 disease
pramlintide in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes. this is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).

participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.other inclusion factors are: * hba1c level between 7.5 and 10% inclusive * currently using carbohydrate to insulin ratio * acceptable form of birth control exclusion factors: * oral hyperglycemic agents or medications which might affect blood sugar levels * recurrent severe hypoglycemia requiring assistance in previous 6 months * diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility * previous use of pramlintide the study consists of 2 overnight stays at the ctrc where a continuous glucose monitoring system will be worn for twenty-four hours. blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. meals will be controlled for carbohydrate, fat and protein content. meals will be identical at each ctrc visit. after a baseline visit for all participants, randomization will occur to either treatment or control.bolus insulin will be adjusted for participants when beginning pramlintide and will likely remain at a reduced rate throughout the trial. all participants will have access to staff to assist with insulin dosing. there will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study. insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final visit of the study. hypoglycemic events will be tracked, as well as any other adverse events.

Eligibility criteria:
inclusion criteria: * between 13 and 17 years of age, inclusive * diagnosed with type 1 diabetes for \> 1 year * hemoglobin a1c between 7.5 and 10% inclusive * currently using carbohydrate to insulin ratio * acceptable form of birth control exclusion criteria: * use of oral hyperglycemic agents or medications affecting blood sugar levels * recurrent severe hypoglycemia requiring assistance in past 6 months * history of hypoglycemia unawareness * history of gastroparesis requiring use of drugs that stimulate gastrointestinal motility * previous use of pramlintide

Keywords: type 1 diabetes adolescents post prandial glucose